Low Pressure Pneumoperitoneum Using AirSeal® for Reduction in Postoperative Shoulder Pain Following Robot Assisted Hiatal Hernia Repair

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRiverside University Health System Medical Center

About this trial

The goal of this clinical trial is to evaluate the incidence and severity of post-operative shoulder pain following elective robot-assisted hiatal hernia repair in hopes of reducing pain and associated costs as well as clinic and emergency department visits due to this pain. You will undergo standard robot-assisted hiatal hernia repair with the standard postoperative care. The only difference is that you may be selected for the group where lower pressures used to fill your abdomen with carbon dioxide will be used, and you will be asked to fill out logs regarding your pain postoperatively. You will have postoperative appointments that are standard following this procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients undergoing elective robot assisted hiatal hernia repair

Disqualifiers

patients less than 18 years of age

conversion to open surgery

BMI > 40

history of abdominoplasty

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low pressure pneumoperitoneum (8-10mmHg) with AirSeal device

    Procedure/Surgery

    Elective robot assisted hiatal hernia repair with low pressure pneumoperitoneum (8-10mmHg) with AirSeal device

  • Standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device

    Procedure/Surgery

    Elective robot assisted hiatal hernia repair with standard pressure pneumoperitoneum (13- 15 mmHg) with AirSeal device

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Low Pressure Pneumoperitoneum (8-10 mmHg)Experimental treatment 1 intervention
Group B: Standard Pressure Pneumoperitoneum (13-15 mmHg)Other 1 intervention

Trial outcomes

Primary outcomes

1

Reduction in post-operative shoulder pain

Percentage reduction in post-operative shoulder pain from POD#0 to \~1 week post-operative telephone appointment

Time frame
1 week (on average)

Secondary outcomes

1

Severity of postoperative shoulder pain on POD #0

Severity of postoperative shoulder pain on POD #0 (recorded at nursing shift change \~7PM)

Time frame
6 hours (on average)
2

Severity of postoperative shoulder pain on POD #1

Severity of postoperative shoulder pain on POD #1 (when surgical team rounds \~6-8AM)

Time frame
18 hours (on average)
3

Severity of postoperative shoulder pain at ~1 week

Severity of postoperative shoulder pain at \~1 week post-operative telephone appointment

Time frame
1 week (on average)
4

Severity of postoperative shoulder pain at ~2 weeks post-op

Severity of postoperative shoulder pain at \~2 week postoperative clinic visit measured by numeric pain rating scale and morphine milligram equivalents

Time frame
2 weeks (on average)

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: